Quick Guide for Reviews of Research Submissions
Table of Contents
There are key expectations for conducting IRB reviews. The following practices will help support efficient and productive discussions during IRB meetings. For more detailed information, please refer to Sections 3, 4, and 5 of the IRB Member Handbook.
Attendance
- Respond to the Doodle Poll as soon as you can so the IRB can plan for a quorum.
- Attend IRB meetings on a regular basis to maintain quorum.
- Arrive on time and stay for the entire session whenever possible.
- Report any scheduled absences as soon as you know you cannot attend so submissions being held for your expertise can be assigned to a different meeting.
Review and Meeting Preparation
- Before the meeting, read and review the studies assigned to you thoroughly and be familiar with all the items on the agenda so that you may participate in the discussions.
- Evaluate assigned protocols to ensure they meet the criteria for IRB approval of research found in 45 CFR 46.111. IMPORTANT NOTE: Your comments and requests for changes or additional information should be clearly related to one or more of the criteria for approval, or to achieve compliance with State regulations and/or University policies.
- If you need additional information that is not provided in the study application or submission attachments, contact the IRB Administrator to request the missing information prior to the meeting so the review can proceed.
- Be familiar with IRB guidelines and template consent documents. If a consent form fulfills the requirements for informed consent as described in 45 CFR 46.116, please refrain from requesting editorial changes to improve it or fix minor typographical errors.
- Complete your reviews as early as possible. The IRB staff screen IRB member comments prior to the meeting, looking for issues that could be resolved with additional clarification or concerns that may lead to the study being Tabled (Returned for Additional Information).
- Enter review comments and questions in OneAegis at least 24 hours prior to the IRB meeting. Write comments as if you are addressing the PI directly and in such a manner that the IRB analysts can quickly and easily relay any significant concerns to the PI and study personnel—either in advance of the meeting, if it seems like doing so could result in a more productive review or after the meeting in a letter.
- Whenever possible, discuss major concerns directly with the study PI prior to the meeting to facilitate review of new protocols and prevent unnecessary returns.
Meeting Participation
- Review Section 5.2 Primary Reviewer System and Meeting Review Process below for details about how to lead the discussion at the meeting.
- Please stay focused with your review comments. Questions raised at the meeting should be relevant to subject safety and ethics. Questions raised out of curiosity or cannot be linked to a criterion for approval, SOP, policy, or law can derail or extend the discussion unnecessarily and are not conveyed to the investigator unless related to safety.
- Please contribute to committee discussions by sharing any knowledge and expertise you have that could address the concerns and questions of other members even if you are not an assigned reviewer.
For members assigned to Expedited Review submissions, please:
- Complete review assignments within 10 days of receipt. If you receive an assignment and you are not available or otherwise unable to do reviews, promptly contact the analyst who assigned it to you to allow for timely reassignment to an alternate reviewer.
- Evaluate assigned protocols that may be reviewed under an expedited review procedure according to the criteria for IRB approval of research found in the 45 CFR 46.111.